| Day 1, Thursday, May 30 |
| 8:30 - 9:00 |
Registration & coffee
|
| 9:00 - 9:15 |
Welcome & Introduction to the course (Marc Benijts - Healixia)
|
| 9:15 - 9:45 |
Overview CTD – Quality related issues (Katrien Van Landuyt - FAMHP)
|
| 9:45 - 10:30 |
Stability in the Pharmaceutical World (Tine Eelen - Johnson & Johnson Innovative Medicine)
|
| 10:30 - 10:45 |
Coffee break
|
| 10:45 - 11:30 |
Drug substance: general requirements (Thomas Drapier - FAMHP)
|
| 11:30 - 12:15 |
Drug substance: synthesis and control during synthesis (Michel Guillaume - Auxilis)
|
| 12:15 - 13:15 |
Lunch break
|
| 13:15 - 14:30 |
Drug substance: impurities (Quality aspects: Eddy Dolusic - FAMHP; Non-clinical aspects: Evelyne Pirotte - FAMHP)
|
| 14:30 - 15:15 |
Drug products: General overview and practical tips (Isabelle Delneuville - FAMHP)
|
| 15:15 - 15:30 |
Coffee break
|
| 15:30 - 16:15 |
Solid oral dosage forms (Valérie Vanhoorne - UGent)
|
| 16:15 - 17:00 |
Parenteral dosage forms (Roland Schots - Roval Pharma)
|
| Day 2, Friday, May 31 |
| 9:00 - 9:45 |
Variations according to Regulation EC 1234/2008 (Roselien Poppe - FAMHP)
|
| 9:45 - 10:30 |
Relevant analytical techniques and method validation (Evelien Wynendaele - UGent)
|
| 10:30 - 11:00 |
Coffee break
|
| 11:00 - 11:45 |
Handling of Variations to Module 3 (Eline Van der Biest & Liesbeth Bogaert - FAMHP)
|
| 11:45 - 12:00 |
Variations: Theoretical & practical application worked out through several case studies - Introduction to the cases (Mixed panel FAMHP & Industry)
|
| 12:00 - 13:00 |
Lunch break
|
| 13:00 - 14:30 |
Work out of case studies in workshops (1) (Mixed panel FAMHP & Industry)
|
| 14:30 - 15:30 |
Work out of case studies in workshops (2) (Mixed panel FAMHP & Industry)
|
| 15:30 - 15:45 |
Coffee break
|
| 15:45 - 17:15 |
Work out of case studies in workshops (3) (Mixed panel FAMHP & Industry)
|
| 17:15 - 17:30 |
Closing Remarks (Marc Benijts - Healixia)
|
